{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-08", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "", "manufacturer_contact_t_name": "MRS.", "manufacturer_contact_state": "CA", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "REDWOOD CITY", "manufacturer_contact_address_1": "150 SHORELINE DRIVE", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3014447948-2022-00007", "type_of_report": [ "Initial submission", "Followup" ], "product_problem_flag": "N", "date_received": "20220615", "manufacturer_address_2": "", "pma_pmn_number": "K193534", "date_of_event": "20220428", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "94065", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "SMITH", "source_type": [ "Study", "Health Professional", "Company representation" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "94065", "manufacturer_g1_state": "CA", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20220615", "manufacturer_contact_f_name": "ANDRIA", "device_date_of_manufacturer": "20210922", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "2869261", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "U", "date_received": "20220615", "brand_name": "MONARCH PLATFORM", "generic_name": "BRONCHOSCOPE (FLEXIBLE OR RIGID) AND ACCESSORIES", "manufacturer_d_name": "AURIS HEALTH, INC.", "manufacturer_d_address_1": "150 SHORELINE DRIVE", "manufacturer_d_address_2": "", "manufacturer_d_city": "REDWOOD CITY", "manufacturer_d_state": "CA", "manufacturer_d_zip_code": "94065", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "94065", "device_operator": "HEALTH PROFESSIONAL", "model_number": "MON-000005-01", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "EOQ", "device_age_text": "DA", "device_evaluated_by_manufacturer": "R", "combination_product_flag": "N", "udi_di": "B634MON000005010", "udi_public": "+B634MON000005010/16D20210922", "openfda": { "device_name": "Bronchoscope (Flexible Or Rigid)", "medical_specialty_description": "Ear, Nose, Throat", "regulation_number": "874.4680", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "NY", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/20/2022", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "US", "date_changed": "20250806", "health_professional": "Y", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20220615", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention", " H" ], "patient_age": "", "patient_sex": "Female", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Pneumothorax", "Pneumothorax" ] } ], "distributor_city": "", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "US", "manufacturer_contact_city": "REDWOOD CITY", "mdr_report_key": "14700524", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20220520", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "94065", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "AURIS HEALTH, INC.", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "N", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "294940957", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS EVENT WAS REPORTED FROM THE TRANSBRONCHIAL BIOPSY ASSISTED BY ROBOT GUIDANCE IN THE EVALUATION OF TUMORS OF THE LUNG (TARGET) STUDY (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. THERE WAS NO ALLEGATION OF DEVICE FAILURE. RISK OF PNEUMOTHORAX IS DOCUMENTED IN 105-000299-01, REV F, MONARCH BRONCH RISK MANAGEMENT REPORT AND IS DEEMED TO BE ACCEPTABLE. BASED ON THE INFORMATION AVAILABLE FOR THIS COMPLAINT, THE ROOT CAUSE OF THE REPORTED EVENT IS RELATED TO A KNOWN INHERENT RISK OF THE DEVICE AND PROCEDURE AS DOCUMENTED IN THE LABELING." }, { "mdr_text_key": "294940958", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT THE PATIENT UNDERWENT A NAVIGATIONAL BRONCHOSCOPY FOR SAMPLING OF THE RIGHT MIDDLE LOBE (RML). A RIGHT-SIDED PNEUMOTHORAX WAS NOTED, AND A PIGTAIL CHEST TUBE WAS PLACED. THE CATHETER WAS SUTURED IN PLACE AND ATTACHED TO-20CMH20 SUCTION. THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION. POST CHEST TUBE PLACEMENT CHEST X-RAYS (CXR) SHOWED RESOLUTION OF THE PNEUMOTHORAX. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY." }, { "mdr_text_key": "331693693", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "A 1004-0-0-0 FAULT INDICATES A PENDANT (CONTROLLER) COMMUNICATION FAULT WHERE THE PENDANT IS DISCONNECTED OR HAVE NOT RECEIVED PENDANT DATA/INFO FOR LONGER THAN 100 MS BY DEFAULT. THE SYSTEM BEHAVED AS INTENDED BY TRIGGERING THE 1004 FAULT WHEN THE CONTROLLER CONNECTOR WAS NOT FULLY IN CONTACT WITH THE PENDANT RECEPTACLE IN THE TOWER DRAWER. HOWEVER, THIS COULD NOT BE CONFIRMED. FAULT 1211 AND FAULT 1200 WERE TRIGGERED WHEN THE SCOPE WAS RETRACTED OUTSIDE TRACHEA. THIS IS AN EXPECTED SYSTEM BEHAVIOR WHEN THE BRONCHOSCOPE TIP LOCATION IS OUTSIDE OF THE SEGMENTED TRACHEA AND EXIT THE FIELD OF VIEW OF THE FG (FIELD GENERATOR). THE ROOT CAUSE OF THE FAULT 1004 CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. FAULTS 1200 AND 1211 ARE EXPECTED SYSTEM BEHAVIOR. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THERE ARE NO REPORTS OF NONCONFORMANCE THAT RELATE TO THE REPORTED INCIDENT. A REVIEW FOR SIMILAR COMPLAINT SHOWS THE REPORTED ISSUE IS A KNOWN ISSUE HOWEVER THE ROOT CAUSE IS SPECIFIC TO EACH INDIVIDUAL CASE. THIS ISSUE WILL BE TRACKED AND TRENDED IN THE MONTHLY COMPLAINT TREND REVIEW MEETINGS. RISK DOCUMENT NUMBER: 105-000367-00, REV. M, DFMEA BRONCH 2.0; DFMEA TOWER PLATFORM 2.0, 105-000345-00 REV. I" } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "150 SHORELINE DRIVE", "distributor_zip_code": "", "manufacturer_contact_postal_code": "94065", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "07/18/2022" } ] }